UNC IRB clarifies promotion guidelines for study listings
New UNC SOP guidelines effective June 2, 2017 require a change to the Join the Conquest study listing form approval for the compensation section only.
Per UNC IRB SOP 220.127.116.11
"… In keeping with the DHHS and FDA guidance, the UNC IRB has determined that the IRB review/approval for brief internet advertisements (e.g., listing of studies on department or research website) is not necessary provided that the information is limited to:
- study title
- purpose of the study
- protocol summary
- basic eligibility criteria
- study site location(s), and
- contact information for the study site
When information posted on a clinical trial website goes beyond directory listings with the basic descriptive information given above, such information is considered part of the informed consent process and therefore requires IRB review and approval…"
To comply with the new SOP, please read and follow the steps below:
If you have a current listing on Join the Conquest and list compensation:
Please submit your study listing form including compensation information to the IRB for approval. Highlight the new information in the compensation area, describing the modification as "adding compensation to JTC listing." Submit under the "Website Recruitment Ads" category of the IRB application section B.1 – Recruitment Types.
In the meantime, please modify your study listing compensation field in JTC by deleting the compensation amount and entering "Contact the Researcher." JTC admin will review and approve the change. When you obtain IRB approval, you can modify the study listing form to include the compensation amount. No need to submit documentation of IRB approval to JTC administration. It is your responsibility to comply with the UNC IRB SOPs.
For future submissions of study listings to Join the Conquest that include compensation:
If you have not already received IRB approval for study listing including compensation, complete your form as usual, but enter "Contact the Researcher" in the compensation field until you receive IRB approval. The JTC admin will approve your study per the usual process. If you have already received approval, then enter the compensation. It is your responsibility to comply with UNC IRB SOPs.
For study listings that do not include compensation:
Complete your study listing and enter "Contact the Researcher" in the compensation field. Submit to JTC as usual.